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Play and Joy Water-Based Lubricant is a water-based personal lubricant, for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyurethane, and polyisoprene condoms.

Play and Joy Water-Based Lubricant is a non-sterile, clear, semi-viscous water-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. Its formulation consists of water, xantham gum, glycerine, Chondrus crispus extract, sodium hyaluronate, saccharide isomerate, hydroxyethylcellulose, citric acid, sodium citrate, lactic acid, 1,2-pentanediol, phenoxyethanol, iodopropynyl butylcarbamate, hydroxyacetophenone, gluconolactone, and sodium benzoate. Play and Joy Water-Based Lubricant is for over-the-counter use and is provided in volumes of 50 mL and 100 mL in polyethylene tubes closed with polypropylene caps.

The provided document is a 510(k) Summary for a medical device called "Play and Joy Water-Based Lubricant." It is a submission to the FDA demonstrating substantial equivalence to a predicate device.

This document does not contain the type of acceptance criteria and study information (such as AI performance metrics, sample sizes for test/training sets, expert qualifications, or adjudication methods) typically found for AI/ML-driven medical devices.

The product described is a personal lubricant, and the performance testing focuses on its physical characteristics, biocompatibility, and condom compatibility, not on an AI algorithm's diagnostic performance. Therefore, I cannot extract the information requested in your prompt regarding AI device acceptance criteria and study data from this document.

However, I can provide the acceptance criteria and performance data for the mechanical/physical performance of the lubricant as reported in the document:

1. A table of acceptance criteria and the reported device performance

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Play & Joy InvisiLube Lubricant Capsule is a personal lubricant for over-the counter use, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms

Play & Joy InvisiLube Lubricant Capsule is a personal lubricant for over-the counter use, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Play & Joy InvisiLube Lubricant Capsule is a non-sterile, anhydrous silicone inner component encapsulated with a gelatin shell. It is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The inner component is composed of a blend of silicone with primary ingredients: Cyclopentasiloxane, Dimethiconol, and Dimethicone. The gelatin shell is composed of gelatin, glycerin, Phatic acid, and water.

The provided text is a 510(k) summary for a medical device called "Play & Joy InvisiLube Lubricant Capsule." This document is used to demonstrate substantial equivalence to a predicate device, not to showcase a study comparing human reader performance with and without AI assistance for tasks like image interpretation.

Therefore, the requested information regarding acceptance criteria and a study proving device performance in the context of AI assistance (e.g., sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training/test sets) is not applicable to this specific document.

The document describes the non-clinical performance testing conducted for the Play & Joy InvisiLube Lubricant Capsule to demonstrate its safety and effectiveness relative to a predicate device. This includes:

1. A table of acceptance criteria and the reported device performance (Non-clinical Specifications):

Regarding the other points, they are not relevant to this type of device and study:

• 2. Sample size used for the test set and the data provenance: Not applicable. The tests are laboratory-based performance and biocompatibility studies, not clinical studies with patient data.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for these tests is based on established testing standards (e.g., USP, ISO, ASTM).
• 4. Adjudication method: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic device.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• 7. The type of ground truth used: For non-clinical tests, the "ground truth" is defined by the specific parameters and limits set by the referenced standards (e.g., sterility limits, pH ranges, cytotoxicity assays).
• 8. The sample size for the training set: Not applicable. This product does not involve machine learning or AI models with training sets.
• 9. How the ground truth for the training set was established: Not applicable.

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Playground For All Love Sesh is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Playground For All Love Sesh is a non-sterile, unscented, water-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of Water. Glycerin, Propanediol, Bamboo Bioferment PF, Sodium Hyaluronate, CMC Cellulose, Citric Acid, Carubba Blend, Tocopheryl Acetate, Sodium Benzoate, Potassium Sorbate. Playground For All Love Sesh is for over-the-counter (OTC) use and is offered in 3.7 fl. oz PET bottles and 0.17 fl. oz PET/Foil packettes.

The provided document describes the "Playground For All Love Sesh" personal lubricant (K222567) and its clearance by the FDA based on substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device specifications outlined in Table 1 (page 4) indicate the acceptance criteria, and the "Summary of Non-Clinical Performance Testing" (pages 5 and 6) reports that the device meets these.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each specific test (e.g., how many batches were tested for viscosity, or how many samples for biocompatibility).

• Biocompatibility: Performed according to the 2020 FDA guidance document Use of International Standard ISO 10993-1. These are standard in-vitro and in-vivo tests that follow established protocols, but specific sample numbers (e.g., number of cells for cytotoxicity, number of animals for sensitization/irritation/toxicity) are not provided.
• Shelf-Life: "Real-time testing" was used, but the number of samples or batches tested longitudinally over the 6-month shelf-life is not specified.
• Condom Compatibility: Evaluated in accordance with ASTM D7661-10(R) 2017. This standard specifies methodological details, but the specific number of condoms or lubricant applications tested is not detailed in this summary.

Data Provenance: The studies are described as "Non-Clinical Performance Testing" conducted by the manufacturer or their designated labs as part of the submission to the U.S. FDA. The country of origin of the data is not explicitly stated but is implicitly tied to the U.S. regulatory process. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. For non-clinical tests like those conducted for a personal lubricant, the "ground truth" is typically established by objective, standardized laboratory measurements and interpretations by trained laboratory personnel or toxicologists, rather than a panel of clinical experts.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple readers or clinicians, to reach a consensus for ground truth. The tests performed here are laboratory-based, objective measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. This type of study is relevant for medical devices, particularly AI-driven diagnostic tools, where multiple human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a personal lubricant, which does not involve human readers for interpretation.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

A standalone performance study was not done in the context of an "algorithm only" as this is not an AI/software device. The entire performance evaluation summarized (biocompatibility, shelf-life, condom compatibility, physical/chemical/microbiological specifications) represents the "standalone" performance of the product itself, without human-in-the-loop interaction in an interpretive sense.

7. Type of Ground Truth Used

The ground truth for the performance claims (e.g., viscosity, pH, microbial counts, biocompatibility outcomes, condom compatibility) is based on objective laboratory measurements and internationally recognized standard test methods (e.g., USP, ISO, ASTM). These standards define specific procedures and criteria for determining whether a product meets a particular specification.

8. Sample Size for the Training Set

This information is not applicable and therefore not provided. The "Playground For All Love Sesh" is a physical product (a personal lubricant), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this type of device.

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Playboy Premium Silicone Lubricant is indicated for penile, vaginal and/or anal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Playboy Premium Silicone Lubricant is a non-sterile, silicone-based personal lubricant for penile, anal, and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of dimethicone. Playboy Premium Silicone Lubricant is sold as an over-the-counter (OTC) product and is provided in 88.7 mL LDPE bottles.

The provided text describes a 510(k) submission for the "Playboy Premium Silicone Lubricant." This is a medical device approval document, not a study evaluating an AI/ML powered device. As such, the specific information requested in the prompt (acceptance criteria and a study proving an AI device meets them, including sample sizes, ground truth, expert opinions, MRMC studies, etc.) is not present in the given text.

The document focuses on demonstrating substantial equivalence to a predicate device (K-Y Silicone K173504) for a personal lubricant. It does this by comparing indications for use, technological characteristics, and non-clinical performance testing.

Here's how the available information relates to the prompt, with the understanding that it's for a traditional medical device, not an AI one:

1. A table of acceptance criteria and the reported device performance

The document provides "Device Specifications" which can be considered acceptance criteria for the physical and biological properties of the lubricant. It also implicitly reports the device performance by stating that it meets these specifications and compares them to the predicate device.

8. The sample size for the training set

This is not applicable. The concept of a "training set" refers to data used to train an AI model. This document describes a traditional medical device, not an AI system.

9. How the ground truth for the training set was established

This is not applicable for the same reasons as point 8.

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The Playboy 3 Contour Condom is used for contraception and for prophylactic purposes (preventing transmission of sexually transmitted infections).

Not Found

I am sorry, but the provided text from the FDA letter about K211450 for the "Playboy 3 Contour Condom" does not contain information about acceptance criteria or a study proving the device meets those criteria, as it relates to device performance metrics typically found in AI/ML medical device submissions.

The document is a 510(k) clearance letter for a condom, outlining its regulatory classification, indications for use, and general controls. It's a standard FDA clearance document that confirms substantial equivalence to a predicate device, rather than a detailed report of performance studies against specific acceptance criteria for an AI/ML device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance.
3. Number of experts or their qualifications for ground truth.
4. Adjudication method.
5. MRMC study information or effect size.
6. Standalone performance.
7. Type of ground truth used.
8. Training set sample size.
9. How ground truth for the training set was established.

This information is typically found in pre-market submissions for AI/ML-powered medical devices, which undergo rigorous validation studies to demonstrate their diagnostic or prognostic capabilities. The provided text concerns a physical barrier contraception device, for which performance is assessed against different types of standards (e.g., burst strength, leakage, etc., though these specific tests are not detailed in this clearance letter).

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For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P1 through P6)

For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P3)

For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 through P3)

For symptomatic relief and management of chronic, intractable pain associated with arthritis. (Choose TENS Mode P4)

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "PlayMakar Sport Muscle Stimulator, Model PRO-500." It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

Specifically, the document includes:

• Trade/Device Name: PlayMakar Sport Muscle Stimulator, Model PRO-500
• Regulation Number: 21 CFR 882.5890
• Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
• Regulatory Class: Class II
• Product Code: NUH, NYN, NYN, NGX
• Indications for Use:
  • For use by healthy adults for the stimulation of healthy muscles in order to improve or facilitate muscle performance.
  • For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
  • For temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
  • For symptomatic relief and management of chronic, intractable pain associated with arthritis.
• Type of Use: Over-The-Counter Use

Missing Information:

The document explicitly states that the FDA has determined the device is "substantially equivalent" to predicate devices. This type of clearance generally relies on demonstrating similarity in technological characteristics and performance to already legally marketed devices, rather than requiring new clinical studies to establish acceptance criteria for novel performance claims.

Therefore, I cannot provide the requested information, which typically pertains to performance studies and acceptance criteria for a device. This document does not describe such studies or criteria.

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Playtex® unscented menstrual tampons are intended to be inserted into the vagina and used to absorb menstrual fluid.

The subject devices, which are modified from the predicate devices, are unscented menstrual tampons consisting of a tampon (pledget with string) and an applicator. The tampons are made of rayon fiber and have absorbency ranges: regular (6-9 grams) and super (9-12 grams). The applicators are made of polyethylene and polypropylene and have four color versions.

The provided text is a 510(k) Summary for the Playtex Stella™ Tampons. It details the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted. However, it does not contain the specific acceptance criteria or the full study details that you requested.

Here's what I can extract and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

The document mentions "color leaching studies" and their analysis using "Tolerable Intake (TI) analysis of each component in the colorant formulation using ISO 10993-17:2002." This implies that the acceptance criteria for these studies would be that any leached components are within tolerable intake levels as defined by ISO 10993-17:2002. However, the specific quantitative acceptance criteria (e.g., maximum allowable concentration of a leached substance) and the actual reported performance (e.g., the measured concentrations) are not provided in this document.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: The document states "The color leaching studies were conducted for new applicators." It does not specify the number of applicators or samples tested.
• Data provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable as the studies described are non-clinical (chemical analysis for leaching, biocompatibility leverage) and do not involve human expert interpretation of data like medical imaging would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable as the studies described are non-clinical, involving chemical analysis rather than human interpretation requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The device is a menstrual tampon, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a menstrual tampon, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the color leaching studies, the "ground truth" would be the established Tolerable Intake (TI) levels for each component, as defined by ISO 10993-17:2002. For the biocompatibility, the ground truth is based on historical data from the predicate device (K132819) which presumably met biocompatibility standards.

8. The sample size for the training set

This section is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This section is not applicable. There is no mention of a "training set."

In summary:

The provided document describes non-clinical testing (color leaching and leveraging biocompatibility data) for a physical medical device (menstrual tampon). It mentions the methodology used (LC-MS, GC-MS, ISO 10993-17:2002 for tolerance) but lacks specific quantitative acceptance criteria or detailed study results and sample sizes that would typically be found in a full study report. The request for information related to AI or expert adjudication is not relevant to this type of device and submission.

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